Abstract
A series of government actions have evolved since the 1990s to facilitate the development of medicinal products for pediatric use using a combination of incentives and mandates. The initiatives have been successful in stimulating activity and interest in products developed for pediatric use. The initiatives continue to evolve as experience accumulates and regulatory agencies develop robust cooperative programs. A multidimensional program is necessary to achieve the necessary goal of aligning pediatric therapeutics with adult therapeutics and providing children the most favorable opportunity to benefit and minimize risk to vulnerable populations.
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Notes
- 1.
Please note that American English spelling is used except where specific terms are referred to, as British English spelling is generally used in Europe.
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Hirschfeld, S., Saint-Raymond, A. (2011). Pediatric Regulatory Initiatives. In: Seyberth, H., Rane, A., Schwab, M. (eds) Pediatric Clinical Pharmacology. Handbook of Experimental Pharmacology, vol 205. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-20195-0_12
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DOI: https://doi.org/10.1007/978-3-642-20195-0_12
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